Ulcerative Colitis

• FDA approval · 2018-02-16
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ENTYVIO (vedolizumab) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2018-02-09
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for SIMPONI (golimumab) submitted by Janssen Biotech, Inc.

• FDA approval · 2017-12-14
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ XR (tofacitinib) filed by Pfizer Laboratories Div Pfizer Inc, enabling the extended-rele…

• FDA approval · 2017-10-17
  FDA Approved: BUDESONIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for Budesonide submitted by Padagis US LLC, expanding regulatory authorization for the product. The …

• FDA approval · 2017-10-13
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for ustekinumab (Stelara) from Janssen Biotech, Inc., potentially expanding indications or updat…

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• FDA approval · 2017-07-27
  FDA Approved: CANASA — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for CANASA (mesalamine) by Allergan, Inc., expanding or updating its labeling.

• FDA approval · 2017-07-27
  FDA Approved: MESALAMINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for mesalamine filed by ANI Pharmaceuticals, Inc.

• FDA approval · 2017-07-27
  FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Mesalamine from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2017-07-27
  FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for LIALDA (mesalamine) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2017-07-21
  FDA Approved: MESALAMINE — Original Application (Zydus Lifesciences Limited)

  FDA approves the original application for MESALAMINE from Zydus Lifesciences Limited for the treatment of ulcerative colitis.

• FDA approval · 2017-06-22
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for Simponi (golimumab) submitted by Janssen Biotech, Inc.

• FDA approval · 2017-06-05
  FDA Approved: MESALAMINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for mesalamine from Zydus Lifesciences Limited, confirming the generic product for inflammatory bowel …

• FDA approval · 2017-04-21
  FDA Approved: RENFLEXIS — Original Application (Organon LLC)

  The FDA approved RENFLEXIS (infliximab) from Organon LLC based on an original application, making it a biosimilar to Remicade. The approval …

• FDA approval · 2016-09-02
  FDA Approved: CANASA — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for CANASA (mesalamine) from Allergan, Inc., expanding/ updating its approved labeling.

• FDA approval · 2016-06-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) to Cordavis Limited, authorizing the continued manufacturing/supply of the p…

• FDA approval · 2016-04-29
  FDA Approved: BUDESONIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for budesonide. The action reflects changes to the product's labeling…

• FDA approval · 2016-04-05
  FDA Approved: INFLECTRA — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved INFLECTRA (infliximab-dyyb) as a biosimilar to infliximab for multiple autoimmune diseases, expanding access to a biologic ther…

• FDA approval · 2016-03-24
  FDA Approved: MESALAMINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for mesalamine submitted by ANI Pharmaceuticals, Inc. This action supplements the existing approval …

• FDA approval · 2016-03-08
  FDA Approved: BUDESONIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a generic budesonide product under an Original Application (ANDA 204548) for Teva Pharmaceuticals USA, Inc. This marks the appr…

• FDA approval · 2016-02-22
  FDA Approved: SIMPONI ARIA — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for Simponi Aria (golimumab) from Janssen Biotech, Inc., under BLA125433, to update the product …

• FDA approval · 2016-02-05
  FDA Approved: BALSALAZIDE DISODIUM — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental ANDA for balsalazide disodium by Apotex Corp., clearing regulatory authorization for this generic ulcerative col…

• FDA approval · 2016-01-26
  FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for mesalamine (Teva Pharmaceuticals USA, Inc.), enabling a modification to the product labeling…

• FDA approval · 2015-11-30
  FDA Approved: BUDESONIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Budesonide from Chartwell RX, LLC, authorizing a change to an existing generic product.

• FDA approval · 2015-11-23
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA approved a supplemental application for Humira (adalimumab) filed by Cordavis Limited, indicating regulatory action on a Humira supp…

• FDA approval · 2015-11-20
  FDA Approved: BUDESONIDE — Supplemental Application (Rite Aid Corporation)

  FDA approved a supplemental application for Budesonide filed by Rite Aid Corporation (ANDA078949), confirming an updated approval for this g…